Comparative effectiveness of traditional Chinese medicine treatment strategies for insomnia: a systematic review and network meta-analysis.

OBJECTIVE

Insomnia causes daytime impairment and reduced quality of life. We evaluated the comparative efficacy and safety of Traditional Chinese Medicine (TCM) treatment strategies for insomnia.

METHODS

Nine databases (PubMed, Embase, Web of Science, Cochrane CENTRAL, ClinicalTrials.gov, CNKI, Wanfang, VIP, SinoMed) were searched through January 2026 for randomized controlled trials (RCTs). Primary outcomes were ISI and PSQI scores; secondary outcomes included clinical efficacy and adverse events (AEs). Data were synthesized using frequentist network meta-analysis.

RESULTS

Twelve RCTs involving 1,260 participants were included, evaluating five strategy nodes: TCM alone, TCM plus Western medicine (WM), WM alone, placebo, and CBT-I. For ISI, TCM plus WM ranked highest (SUCRA 89.7%) and significantly improved scores versus placebo (OR 2.84, 95% CI 1.42-5.68) and WM (OR 1.96, 95% CI 1.08-3.56). For PSQI, TCM plus WM showed the highest probability of improvement (SUCRA 71.9%) with greater reduction versus placebo (MD -2.31, 95% CI -3.65 to -0.97). For clinical efficacy, SUCRA values were 86.6% for TCM plus WM, 77.2% for TCM, 20.9% for WM, and 15.3% for placebo. For AEs (higher SUCRA indicating better safety), SUCRA values were 94.8% for WM, 43.9% for TCM plus WM, 31.1% for placebo, and 30.2% for TCM. Sensitivity analysis excluding secondary insomnia confirmed robust findings.

CONCLUSION

Integrated TCM-WM and TCM therapies demonstrate clinical efficacy and acceptable safety for insomnia management.

SYSTEMATIC REVIEW REGISTRATION: The review protocol was prospectively registered in the International Platform of Registered Systematic Review and Meta-analysis Protocols (INPLASY) (Registration number: INPLASY202680041; DOI: 10.37766/inplasy2026.8.0041).